For the vaccines to be employed at the level they are now, they must be approved by international health regulatory bodies, like the World Health Organization (WHO) or the European Medicines Agency (EMA). Let’s take a look at the requirements for vaccine approval.
The World Health Organization has an Emergency Use Listing Procedure (called “EUL”) that is risk-based. It assesses and lists unlicensed vaccines, therapeutics, and in-vitro diagnostics. The ultimate aim of EUL is to expedite the availability of these products to people affected by a public health emergency [1].
In the case of vaccines, the following criteria to approve vaccines for emergency use must be met:
The disease for which the product is intended is serious or immediately. life-threatening, or has the potential of causing an outbreak, epidemic, or pandemic.
Existing products have not been successful in eradicating the disease or preventing outbreaks.
The product is manufactured in compliance with current Good Manufacturing Practices (GMP) [2].
The applicant needs to complete the development of the product (validation and verification) and apply for WHO prequalification once the product is licensed.
In the case of COVID-19 vaccines, the United Nation’s health branch decided that it has to have an efficacy of at least 50% to be considered for emergency use.
Even though the development of COVID-19 vaccines may seem rushed, all approved vaccines have been extensively evaluated. In order to be approved by WHO, the vaccine manufacturer must submit information about [3]:
Manufacturing quality data
Non-clinical data and clinical data
Plan to monitor quality, safety, and efficacy in the field and an undertaking to submit any new data to WHO as soon as the new data are available
Labeling details.
For more information, you can read “Myth IV: COVID-19 vaccines were rushed” and “From the laboratory bench to the market: the process of making a new vaccine”, or watch this video.
However, even after being granted authorization for distribution, the health regulatory agencies continue monitoring the safety and effectiveness of the COVID-19 vaccines. For example, in the case of the European Medicines Agency, the monitoring includes the following routine activities [4]:
Assessing the way risks associated with the vaccine will be managed and monitored once it is authorized.
Continuously monitoring suspected side effects reported by patients and healthcare professionals, identified in new clinical studies or reported in scientific publications
Regularly assessing reports submitted by the company holding the marketing authorization on the benefit-risk balance of the vaccine in real life
Assessing the design and results of post-authorization safety studies which were required at the time of authorization
It is normal and healthy to have questions and express uncertainty, but misinformation is never a good thing. Let’s stick to the facts and fight COVID-19 together.
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Written by: Phaedra
Edited by: María and Natasha
BioDecoded is a volunteer group committed to sharing accurate scientific information. We cannot offer any specific health advice. If you have any doubts about getting vaccinated due to previous health conditions, please speak with your healthcare professional or family physician. Your doctor can revise your medical history and advise you on the best path to follow. If you have any questions about this topic, please comment or send them to our email.
References:
Diagnostics laboratory emergency use listing. World Health Organization (2021). Available at: https://www.who.int/teams/regulation-prequalification/eul (Accessed: 30th November 2021)
Good Manufacturing Practices. World Health Organization (2021). Available at: https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/gmp (Accessed: 30th November 2021)
Emergency Use Listing Procedure for vaccines. World Health Organization (2021). Available at: https://www.who.int/teams/regulation-prequalification/eul/eul-vaccines (Accessed: 30th November 2021)
Mahase, E. Vaccinating the UK: how the covid vaccine was approved, and other questions answered. BMJ m4759 (2020). Available at: https://www.bmj.com/content/371/bmj.m4759
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